Consent Form for Participation in a Subject Recruitment Database

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Consent Form for Participation in a Subject Recruitment Database
University of Massachusetts Amherst
Name of Researcher:
Name of Subject Recruitment Database:
1. WHAT IS THIS FORM?
This form is called a Consent Form. It will give you information about the Subject Recruitment Database
so you can make an informed decision about whether or not you would like your name and information to
be included in this catalogue of information.
2. WHAT IS THE PURPOSE OF THIS SUBJECT RECRUITMENT DATABASE?
The purpose of this subject recruitment database is …
3. WHO IS BEING ASKED TO PARTICIPATE IN THIS DATABASE?
[Describe the characteristics of desired participants including gender, age, health limitations, medical
conditions, etc. ]
4. WHAT WILL MY PARTICIPATION IN THIS DATABASE INVOLVE?
If you agree to be included in the subject recruitment database ….
[Describe what information will be requested, how it will be obtained, how it will be used, how subjects
may be contacted in the future for studies, how often subjects will be contacted, and explain that there this
is only one of several recruitment databases at UMASS Amherst…]
5. WHAT ARE THE POSSIBLE BENEFITS OF MY PARTICIPATION IN THIS DATABASE?
[Use the following suggested statement for this section:]
“You may not directly benefit from being included in this database; however, we hope that your inclusion
in the database may …(describe societal benefits).”
6. WHAT ARE THE POSSIBLE RISKS OF MY PARTICIPATION IN THE DATABASE?
[Inform the participant of any risks associated with being included in the database (mainly
confidentiality?)]
7. HOW WILL MY PERSONAL INFORMATION BE PROTECTED?
[Describe protections that you will use to keep the electronic or hard copy information secure. How will
you provide information to colleagues eligible to use the data?] For example:
“The researchers will keep all database records in a secure location. All electronic files (e.g., database,
spreadsheet, etc.) containing identifiable information will be password protected. Any computer hosting such
files will also have password protection to prevent access by unauthorized users.”
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8. WHO WILL HAVE ACCESS TO MY INFORMATION?
Only the members of the research staff will have access…
[If database information is to be released, describe the person(s) to whom information will be furnished, the
nature of the information to be furnished, the purpose of the disclosure and whether the participant’s name
will be used.]
9. WHAT IF I HAVE QUESTIONS?
[Include the following required information on all consent forms].
“Take as long as you like before you make a decision. We will be happy to answer any question you have
about this study. If you have further questions about this database you may contact [insert name and phone
number of database researcher]. If you have any questions concerning your rights as a research subject,
you may contact the University of Massachusetts Amherst Human Research Protection Office (HRPO) at
(413) 545-3428 or humansubjects@ora.umass.edu.
10. MAY I WITHDRAW MY CONSENT FOR PARTICIPATION IN THE DATABASE?
[Required statement to begin section:]
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“You do not have to be a part of this database if you do not want to. If you agree to be in the database, but
later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if
you decide that you do not want to participate.”
11. SUBJECT STATEMENT OF VOLUNTARY CONSENT
[Use the following required statement and format for this section:]
“I have read this form and decided that I will participate in the subject recruitment database. The general
purposes and particulars of the database as well as possible hazards and inconveniences have been
explained to my satisfaction. I understand that I can withdraw at any time.”
________________________
Participant Signature:
____________________
Print Name:
__________
Date:
By signing below I indicate that the participant has read and, to the best of my knowledge, understands
the details contained in this document and has been offered a copy.
_________________________
Signature of Person
Obtaining Consent
____________________
Print Name:
__________
Date:
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